rimabotulinumtoxinb

Therapeutic Classification: antispasticity agents, cosmetic agents

Pharmacologic Classification: neurotoxins

Indications ⬆ ⬇

REMS

Cervical dystonia.
Chronic sialorrhea.

Action ⬆ ⬇

Inhibits release of acetylcholine from peripheral cholinergic nerve endings, resulting in chemical denervation of treated muscle.

Therapeutic effects:

Localized reduction of muscle activity, with decrease in spasticity, abnormal head position and neck pain related to cervical dystonia.
Reduction in unstimulated salivary flow.

Pharmacokinetics ⬆ ⬇

Absorption: Minimal; not expected to be present in peripheral blood when used at recommended doses.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(improvement in spasticity)

ROUTE	ONSET	PEAK	DURATION
IM	within 4 wk	unknown	up to 4 mo

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to botulinum toxin products or additives;
Infection at injection site.

Use Cautiously in:

Compromised respiratory function or dysphagia;
Peripheral motor neuropathic disorders (may exacerbate clinical effects and ↑ the risk of severe dysphagia and respiratory compromise);
Patients with smaller neck muscle mass and those requiring bilateral sternocledomastoid injections (↑ risk of dysphagia, smaller doses may be necessary);
OB: Use only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: Use cautiously in older adults; consider concurrent diseases and drug therapy.

Adv. Reactions/Side Effects ⬆ ⬇

GI: dry mouth, dysphagia, dyspepsia, nausea

Local: injection site pain

MS: muscle weakness, neck pain

Neuro: headache

Resp: breathing difficulties

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), SPREAD OF TOXIN EFFECT

Interactions ⬆ ⬇

Drug-drug:

Concurrent use of aminoglycosides or other agents interfering with neuromuscular transmission including curare-like agents or muscle relaxants may ↑ effect.
Concurrent use of anticholinergics↑ systemic anticholinergic effects

Route/Dosage ⬆ ⬇

Note: Doses are NOT interchangeable with other botulinum toxin products.

Cervical Dystonia

IM (Adults ): Prior history of tolerating botulinum toxin injections: 2500–5000 units divided among affected muscles; subsequent dosing should be based on patient's individual response; No prior history of tolerating botulinum toxin injections: Use lower initial dose.

Chronic Sialorrhea

Intraglandular(Adults ): 1500–3500 units divided among the parotid (500 to 1500 units/gland) and submandibular (250 units/gland) glands; subsequent dosing should be based on patient's individual response (do not administer more frequently than every 3 mo).

Availability ⬆ ⬇

Solution for local injection: 2500 units/0.5 mL; 5000 units/mL; 10,000 units/2 mL

Assessment ⬆ ⬇

Assess amount of spasticity prior to and following therapy.
Monitor for signs and symptoms of spread of toxin (asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties). May occur hours to weeks after injection.

Lab Test Considerations:

May cause slight ↑ of blood glucose.

Implementation ⬆ ⬇

The potency units of rimabotulinumtoxinb are not interchangeable with other botulinum toxin products.
May be diluted with 0.9% NaCl without preservatives. Swirl gently to dissolve; do not shake. Solution should be clear and colorless to light yellow; do not administer solutions that are discolored or contain particulate matter. Refrigerate solution and protect from light; do not freeze. Use each single-dose vial for 1 session and only for 1 patient. Discard any remaining solution in vial.
IM: Administer into affected muscles within 4 hr using a 23 or 25 gauge needle.
Intrasalivary gland: Use a 30-gauge, 0.5 inch needle.

Patient/Family Teaching ⬆ ⬇

Inform patient of purpose of rimabotulinumtoxinb. Advise patient to read Patient Medication Guide prior to treatment.
Inform patient that effects of rimabotulinumtoxinb may spread beyond the site of local injection. Advise patient to notify health care professional immediately if problems swallowing, speaking, or breathing occur or if signs and symptoms of spread (asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysarthria, urinary incontinence, breathing difficulties) occur. May occur hrs to wks after injection.
May cause loss of strength, muscle weakness, blurred vision, or drooping eyelids. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇